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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET 360 NANO 2 MM X 4 CM; DEVICE, NEUROVASCULAR EMBOLIZATION
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STRYKER NEUROVASCULAR CORK TARGET 360 NANO 2 MM X 4 CM; DEVICE, NEUROVASCULAR EMBOLIZATION Back to Search Results
Catalog Number M0035442040
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Aneurysm (1708); Stroke/CVA (1770); Dementia (1808); Hemorrhage, Intraventricular (1892); Dysphasia (2195); Rupture (2208)
Event Date 10/19/2015
Event Type  Injury  
Manufacturer Narrative
The device was disposed in the hospital.
 
Event Description
It was reported that the unruptured left supraclinoid internal carotid artery (ica) aneurysm was ruptured as the first subject coil loop was attempting to be positioned within the aneurysm.The coil that caused the rupture was not implanted but was removed.Balloon assisted coil embolization was performed to treat complications.Post procedure, imaging revealed a left anterior choroidal territory stroke with small amount of intraventricular hemorrhage.The patient suffered hospital delirium and mild aphasia.Four (4) days post procedure, the patient was discharged in the rehabilitation center and twelve (12) days later was discharged home.The event was related to the subject device and procedure.
 
Manufacturer Narrative
The device history record review confirmed that the devices met all material, assembly and performance specifications.The subject device is not available; therefore, functional testing as well as physical analysis cannot be performed.Aneurysm rupture, hemorrhage, stroke, and neurological/intracranial sequelae are known risk associated with endovascular procedures and are listed as such in the device directions for use (dfu).Therefore, an assignable cause of anticipated procedural complications was assigned to this event.
 
Event Description
It was reported that the unruptured left supraclinoid internal carotid artery (ica) aneurysm was ruptured as the first subject coil loop was attempting to be positioned within the aneurysm.The coil that caused the rupture was not implanted but was removed.Balloon assisted coil embolization was performed to treat complications.Post procedure, imaging revealed a left anterior choroidal territory stroke with small amount of intraventricular hemorrhage.The patient suffered hospital delirium and mild aphasia.Four (4) days post procedure, the patient was discharged in the rehabilitation center and twelve (12) days later was discharged home.The event was related to the subject device and procedure.
 
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Brand Name
TARGET 360 NANO 2 MM X 4 CM
Type of Device
DEVICE, NEUROVASCULAR EMBOLIZATION
Manufacturer (Section D)
STRYKER NEUROVASCULAR CORK
ida industrial estate
model farm road
cork NA
Manufacturer (Section G)
STRYKER NEUROVASCULAR CORK
ida industrial estate
model farm road
cork NA
Manufacturer Contact
sanda dracic
47900 bayside parkway
fremont, CA 94538
5104132500
MDR Report Key5261403
MDR Text Key32528618
Report Number3008853977-2015-00493
Device Sequence Number1
Product Code HCG
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K113412
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type study
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 11/09/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Expiration Date03/30/2018
Device Catalogue NumberM0035442040
Device Lot Number18317432
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 11/09/2015
Initial Date FDA Received12/02/2015
Supplement Dates Manufacturer ReceivedNot provided
Supplement Dates FDA Received02/10/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured05/21/2015
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Other; Required Intervention;
Patient Age61 YR
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